Second-line Intravenous Treatment For Recurrent Platinum-Sensitive Ovarian, Fallopian, Or Peritoneal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00061308|
Recruitment Status : Completed
First Posted : May 28, 2003
Last Update Posted : June 9, 2017
This research study was designed to determine the effectiveness of the drug, topotecan, given intravenously (into a vein) together with the drug gemcitabine in patients with recurrent platinum-sensitive ovarian, fallopian or primary peritoneal cancer, as well as tumors of mixed mullerian origin. Additional purposes are to determine the long term outcome and side effects of this combination treatment.
Since topotecan and gemcitabine have different mechanisms of action, the combination of these 2 drugs may provide better results than either drug alone. Prior studies suggest that the combination of topotecan and gemcitabine improves the effects on the tumor and also appeared to be well tolerated.
|Condition or disease||Intervention/treatment||Phase|
|Peritoneal Cancer Ovarian Cancer Neoplasms, Ovarian Fallopian Tube Cancer||Drug: Topotecan Drug: Gemcitabine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multicenter, Non-Comparative Phase II Study of the Combination of Intravenous Topotecan and Gemcitabine Administered Once Weekly for Three Weeks Every 28 Days as Second-line Treatment in Patients With Recurrent Platinum Sensitive Ovarian Cancer|
|Study Start Date :||December 2002|
|Primary Completion Date :||September 2004|
U.S. FDA Resources
- response rate
- response duration time to response time to progression survival safety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061308
Show 19 Study Locations
|Study Director:||GSK Clinical Trials, MD, PhD||GlaxoSmithKline|